Vortex SSAX-16-IRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI H787SSAX16I0), received between Jun 20, 2018 and Feb 26, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K032557); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Fracture; Detachment of Device or Device Component; Infusion or Flow Problem

  ON OR ABOUT (B)(6) 2007, PLAINTIFF UNDERWENT PLACEMENT OF DEFENDANTS' VORTEX PORT CATHETER DEVICE, WITH MODEL NUMBER SSAX-16-1, AND LOT NUMBER 27839. THE VORTEX WAS IMPLANTED BY DR. (B)(6), AT (B)(6) HOSPITAL (B)(6). ON OR ABOUT (B)(6) 2007, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL (B)(6) FOR REMOVAL OF THE VORTEX GIVEN THE DEVICE WAS NO LONGER NEEDED AND WAS NOT FLUSHING PROPERLY. ON OR ABOUT (B)(6) 2007, DR. (B)(6) ATTEMPTED TO REMOVE THE VORTEX DEVICE, AND WHILE HE WAS ABLE TO REMOVE THE PORT BODY ITSELF, HE DISCOVERED THAT THE CATHETER PORTION OF THE DEVICE HAD FRACTURED AND MIGRATED. PLAINTIFF UNDERWENT IMAGING, WHICH CONFIRMED A FRAGMENT OF THE FRACTURED CATHETER REMAINED IN HIS BODY. ON OR ABOUT (B)(6) 2007, PLAINTIFF PRESENTED TO (B)(6) HOSPITAL IN (B)(6) TO UNDERGO RETRIEVAL OF THE FRACTURED CATHETER FRAGMENT. THE RETRIEVAL PROCEDURE WAS PERFORMED BY DR. (B)(6), AND SHE WAS ABLE TO SUCCESSFULLY RETRIEVE THE ENTIRE CATHETER FRAGMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24465480 ↗
• InjuryNov 30, 2023Difficult to Remove; Detachment of Device or Device Component; Migration; Difficult to Remove; Detachment of Device or Device Component; Migration

  A LEGAL FIRM REPORTED AN ADVERSE EVENT ASSOCIATED WITH A TRIUMPH VORTEX PORT ATT W/ 10F INTRO KIT PG. THE FOLLOWING WAS REPORTED: -ON OR ABOUT (B)(6) 2021, PLAINTIFF UNDERWENT IMAGING, WHICH DEMONSTRATED A CATHETER FRACTURE. THE FRAGMENT WAS POSITIONED IN THE BASE OF PLAINTIFF'S RIGHT ATRIUM AND RIGHT VENTRICLE. - ON OR ABOUT (B)(6) 2021, PLAINTIFF PRESENTED HERSELF TO (B)(6) MEDICAL CENTER IN (B)(6) FOR FRAGMENT RETRIEVAL. AFTER MULTIPLE ATTEMPTS, PLAINTIFF'S MEDICAL TEAM WERE UNABLE TO RETRIEVE THE CATHETER FRAGMENT. -ON OR ABOUT (B)(6) 2021, PLAINTIFF UNDERWENT A SECOND SURGERY TO REMOVE THE CATHETER FRAGMENT FROM HER RIGHT ATRIUM AND RIGHT VENTRICLE. AFTER MULTIPLE ATTEMPTS, PLAINTIFF'S MEDICAL TEAM WERE ONCE AGAIN UNABLE TO RETRIEVE THE FRAGMENT. PLAINTIFF WAS REFERRED TO AN INTERVENTIONAL CARDIOLOGIST FOR FURTHER ASSESSMENT AND TREATMENT. -ON OR ABOUT (B)(6) 2021, PLAINTIFF PRESENTED HERSELF TO (B)(6) HOSPITAL IN (B)(6) FOR FRAGMENT RETRIEVAL. AFTER MULTIPLE ATTEMPTS, PLAINTIFF'S MEDICAL TEAM WERE UNABLE TO RETRIEVE THE CATHETER FRAGMENT. -ON OR ABOUT (B)(6) 2022, PLAINTIFF RETURNED TO (B)(6) FOR A FOLLOW-UP APPOINTMENT, WHERE HER MEDICAL TEAM DETERMINED THAT THE RISKS OF FUR

  Patient problems: Foreign Body In Patient

  MAUDE report 18242402 ↗
• InjuryJun 20, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  AS REPORTED, DURING REMOVAL OF AN IMPLANTED PORT AT (B)(6) MEDICAL CENTER THE CATHETER FRACTURED. THE PATIENT HAD TO BE TRANSFERRED TO ANOTHER FACILITY BECAUSE NO INTERVENTIONAL RADIOLOGIST WAS AVAILABLE AT (B)(6) MEDICAL CENTER. NO PATIENT INJURY WAS REPORTED. THE USED DEVICE HAS BEEN DISCARDED AT THE HOSPITAL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7618692 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032557. One submission often covers many models, so check the product and lot details in each record.

• Z-0403-2011 · Sep 27, 2010 · Terminated
  Vortex TR, AngioDynamics, Inc., One Horizon Way, Manchester, GA 31816